NCT02970786

Phase I Trial: 68Ga-NODAGA-E(c[RGDyK])2 Positron Emission Tomography for Imaging Angiogenesis in Primary and Metastatic Tumor Lesions in Humans

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the trial is to test the new radio tracer 68Ga-NODAGA-E\[c(RGDyK)\]2 for PET imaging of angiogenesis. The tracer has the potential of identifying tumors with a high level of angiogenesis, which is one of the cancer hallmarks. Furthermore, the tracer can potentially be used in early response assessment to anti-angiogenic treatment. This is a first-in-man study to test the radio tracer in cancer patients. Safety, biodistribution and dosimetry will be evaluated by repeated PET imaging (10 minutes, 1 hour and 2 hours post injection).

Detailed description

The primary objective of the trial is to test the new radio tracer 68Ga-NODAGA-E\[c(RGDyK)\]2 for PET imaging of angiogenesis. The tracer has the potential of identifying tumors with a high level of angiogenesis, which is one of the cancer hallmarks. Furthermore, the tracer can potentially be used in early response assessment to anti-angiogenic treatment. This is a first-in-man study to test the radio tracer in cancer patients. Safety, biodistribution and dosimetry will be evaluated by repeated PET imaging (10 minutes, 1 hour and 2 hours post injection). The primary end points are safety, biodistribution and dosimetry of 68Ga-NODAGA-E\[c(RGDyK)\]2. In addition, the quantitative uptake of 68Ga-NODAGA-E\[c(RGDyK)\]2 will be compared to the expression of integrin αvβ3 measured directly in tumor tissue obtained by surgery or biopsies. The study will be monitored and evaluated in accordance with the principles of Good Clinical Practice (GCP).

Conditions

• Neuroendocrine Carcinoma
• Breast Cancer
• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Injection of 68Ga-NODAGA-E(c[RGDyK])2	Following one injection of 68Ga-NODAGA-E(c\[RGDyK\])2 the patients will be PET scanned at 10 minutes, 1 hour and 2 hours post injection

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-06-01
• First posted: 2016-11-22
• Last updated: 2016-11-22

Locations

1 site across 1 country: Denmark